Congratulations to my new friends Paolo Bianco, M.D., of Sapienza University of Rome (pictured at left), Elena Cattaneo, Ph.D., of University of Milan and Michele De Luca, M.D. of University of Modena and Reggio Emilia (photo in the middle of the post), for receiving the 2014 ISSCR Public Service Award.

Drs. Bianco, Cattaneo, and De Luca are all great members of the stem cell community who have worked very hard for evidence-based medicine in Italy. Their efforts particularly resonate to the crisis surrounding the Stamina Foundation, but have had broader positive impact as well.

ISSCR described the award-winning efforts of these three outstanding members of the stem cell community in this way:

Award recipients Bianco, Cattaneo and De Luca were selected for their recent involvement in public debate and policy-making in Italy, championing rigorous scientific and medical standards and stringent regulatory oversight in the introduction of new stem cell treatments into the clinic.

As an update, I recently sent a check for the $1,000 prize that Cattaneo has generously contributed to a science fellowship program. That tells what you what kind of person she is. How awesome.

I also found it great that ISSCR took somewhat of a pioneering step, compared to past years’ awards, with this year’s public service award by giving it to scientist advocates! Way to go ISSCR! Of course the past recipients of this award are incredible in their own right, but I just think it is outstanding that ISSCR chose to give the award this year to scientists who go the extra mile to make a difference in the wider stem cell community, often requiring great courage and burning the midnight oil as advocates.

13 Comments

you deserve praise for drawing attention to the dangers of current stem cell treatments; however, in itself I feel it is like banning alcohol and prostitution. None of them has worked. It just increased the revenues of criminals. If I may suggest informing people regularly about ongoing clinical trials might help more. If patients can see that there is something legitimate that might be available in the coming years would give them hope and most likely many would wait. Just saying that something is bad will not solve the problem.

As for Stamina, reading about legitimate clinical trials conducted by Neuralstem, Stemcells Inc., ACT, BioTime, Neurogeneration, (just to name a few) etc. with neural stem cells would help to deter people from current scam operations rather than just repeating the old mantra ‘it is bad for you’. If you really want to do something for patients’ safety, write about ongoing clinical trials and their potentials.

Hi Steve,
Thanks for the comment. I can definitely see some of your points. I do try to include both positives going on and negatives, but sometimes it shifts more one way than the other. Part of the reason I think that sometimes I focus more on the dangers/concerns is that there are some cheerleaders for the dubious clinics that are constantly promoting them and at the same time attacking anyone who supports regulatory oversight so I think there needs to be balance there too. It’s tricky though I admit. Thanks again. Paul

Steve is absolutely on target Paul. I am sure I am one of those you consider a cheerleader, but your constant negative blogging is having the opposite effect of what you would like it to have in the patient community.

I have asked for more information on your own research. I would love to know how far in the future we might expect similar clinical trials to what Japan is doing. You also said you were writing to the FDA and would share that with readers. Instead, it is almost like a daily poke in the eye telling patients that they don’t know what’s good for them.

Even today’s blog about your new “friends” is over the top because of the patient movement concerning Stamina. You don’t explain the situation well and it appears that every time patients try to access treatment, it is just a given that it must be bad. I am not supporting Stamina or those opposed to it, I have no dog in the fight, but I am stating that so much focusing on the negatives is creating a lot of skepticism in the patient community. We communicate with each other a lot and see some patients getting impressive results. How can that be bad and risky?

Your message is simply not resonating to the patient audience because most of us have diseases we see as far riskier than treatment. Please start concentrating on the positives. I have asked this of you before. You would find a far more receptive patient audience (if that’s what you want) if you did so.

Barbara, while I understand your POV, Paul walks a very fine line. Wanting to provide accurate information to the public concerning stem cell research (particularly pluripotent stem cell research) in layman’s terms, while also remaining true to his background as a scientist. I may be wrong, but I think the point of his blog is more educational than it is about making sure the potential patient audience is receptive. Frankly, there’s probably drones at biotech companies that are doing that full time with a lot less expertise than Paul has to offer.

As a scientist myself, I think it’s safe to say that scientists are natural nay-sayers. It is our mentality to question everything, look at the facts, and test/experiment accordingly. Not being easily excitable or easily prone to positivity is the mindset that produces real, reproducible scientific results.

There are likely many many blogs our there that will tell you about how great stem cells are, blogs that will make you feel warm and fuzzy about the possibilities of stem cells, my first suggestion would be to check out the CIRM website for that, but I would argue that Paul generally does a damn good job of telling it how it is and that’s frankly the message that the public needs to hear. A resounding “WAIT!”.

The good times will come, the technology will mature, the promises will be kept, but in time. And while I understand that provides little to no solace for those with short time lines and incurable diseases, the implication that going to one of these clinics is akin to roulette, and therefore ‘why not give it a shot?’, is simply not fair. In the case of pluripotent stem cell therapies at least, I’d argue the odds of one of these quack doctors providing a significant benefit are more like winning the lottery. I don’t like those odds, even on my deathbed, and chances are that the procedure comes with an exorbitant price tag, a lot of jargon, and empty promises… don’t be a victim. As the saying goes, if it sounds too good to be true, it probably is.

My personal frustration with these sort of clinics is that, in all likelihood, they aren’t using stem cells at all, they just jack you full of some placebo that may or may not be cell based, and then pat themselves on the back, pointing to a handful of cases as proof that they are providing the miracle cure you’re looking for, taking in huge profits for an unproven placebo. Meanwhile, companies like Geron, one of the first companies to commercialize stem cell research, shutdown their whole stem cell arm of the company. Some of the best and brightest stem cell scientists in the country are barely surviving financially, not getting much in the way of grants, and are constantly under scrutiny for the validity of their results. If you want speed, if you want results, talk to CIRM, talk to the FDA, talk to the professors and researchers at the top universities researching the disease you want a cure for and ask them “Where do you get your funding?” or “What organization can I donate to that will help your research?”

I know that all stem cell scientists passionately believe, as you may as well, that stem cells have a significant role to play in the future of healthcare and regenerative medicine, but a midst all the excitement, it’s important to remain level headed, to understand that at the current time there are a lot of scams out there, and it would be amiss for Paul, or any scientist worth his salt to imply otherwise.

I don’t see Paul as negative, so much as a voice of reason amongst a growing number of uneducated or more often under-educated stem cell ‘advocates’, many with MDs even, that have lead the public to believe that pluripotent stem cell technology is ready for ‘prime time’ and we’re just being overly cautious, when in actuality, that is simply not the case. Researchers are just as keen (if not more so) to push effective, life saving therapies out of the lab and into the clinic.

So, rather than try to skew Paul’s words, if you want hope, go to the big company websites, go to CIRM’s website and see all the great work being done, go to clinicaltrials.gov and do some researching, but if you want straight-up, no non-sense stem cell information from a researcher with nothing to gain from you getting injected with stem cells, then Paul is your man (and if you don’t want any sugar coating at all, I’m happy to talk to you further as well).

**NOTE: It’s important to recognize that adult (or mesenchymal) stem cell research is often mixed up with pluripotent/embryonic research and that these are separate albeit related fields of research promising very different things, with very different limitations.**

Jordan – I think you are confused as to my point. Take all the time necessary to research and develop iPS and esc therapies. You will get little argument from me (perhaps investors would not be so happy), but adult stem cell procedures fall under the practice of medicine in my opinion and the continual negative speculative preaching about risks from those who are not ill, have never visited a clinic (even when issued an invitation) is simply something that patients are tuning out. What Steve was getting at I think and what I am saying is that it isn’t educating anyone to just keep repeating that something is bad. After awhile, it just gets tuned out especially when patients hear about other patients who are improving their quality of life after receiving autologous stem cell treatment. When I stated I would like to read more about Paul’s research, it was sincere.

Some of your comments indicate to me that you have somehow formed an opinion of doctors and commercial clinics offering stem cell treatment and are lumping them all together as factories churning out concoctions of who knows what administered by quacks who are making a fortune. I’m sorry to disappoint you but I am in a clinical study (IRB, informed consent, etc.), the doctor is someone I have gone to for years, long before he started doing stem cell therapies and he is well respected. The charge to participate is reasonable. My lung function has increased by 7% and my quality of life is vastly improved. I know many patients who have had the same experience with other doctors. I have lost many friends who were not as fortunate as I to be able to access treatment. The university/regulatory “we” should be able to choose what the common man needs, wants, and should have, cost them their lives. I have no doubt of that.

If you became chronically or terminally ill, you have the right to die a safe, most likely painful, lingering death, but I have chosen instead to opt for stem cell therapy. There is too little actual clinical experience in the research community and it shows. My suggestion would be to call a clinic and ask for a visit. Sit down and talk with the owner and the doctors and patients who have been treated instead of just being an armchair critic.

CIRM has been criticized a lot as well as being praised. I do take time to go to their site and also to read news about how funds are being spent. I don’t consider myself or other patient advocates I know uneducated or undereducated. Education also comes with real life experience and that is what seems to be lacking for too many who are criticizing patients, not bothering to even try to learn anything from our experience. We are dismissed as unintelligent beings who most likely are experiencing the placebo effect if we feel better after having an “unproven, risky” stem cell treatment administered most likely by an undereducated doctor.

Paul is not my man. I already have a wonderful man who is thrilled at my being able to do things with him again. I actually resent you saying such a thing.I doubt if Paul would be very thrilled either. I don’t know Paul on a personal level, but if he was my man, he would have had to give in to my desire to have stem cell treatment or wear earplugs 24/7. He then would have had to admit that the difference from before treatment and after is like day and night. He would most likely be overjoyed as is my husband, but how would that fly with the research community? That would create quite a conundrum.

Everyone in this industry has a conflict of interest except for patients. There is just no sugar coating that fact. Money for research, money for patents and company spin offs, administrative dollars taken by universities, money for FDA IND filings that support 1/3 of its budget. Even doctors make a profit from patients they treat. I don’t expect a system of socialized medicine where no one profits, but because of these conflicts, patients are being denied access to treatments they want and need.

Dear Jordan,
“…Wanting to provide accurate information to the public concerning stem cell research (particularly pluripotent stem cell research) in layman’s terms, while also remaining true to his background as a scientist.I may be wrong, but I think the point of his blog is more educational than it is about making sure the potential patient audience is receptive.”
you are really missing the point of Barbara. Barbara and others want accurate and educational information and not repeating the same old story about how dangerous the stem cell treatments abroad. Please do not degrade the readers here, even if they are not ‘scientists’. Ouch, ‘scientist’ is the buzzword? What do you mean by that you are a scientist? If someone is a scientist then he is already an expert of stem cells, but if you are a medical doctor, lets say a neurologist then you know less about the application of stem cells in neural diseases? There are many bright, educated people reading this site even if they are not ‘scientists’ and they can understand more than ‘don’t do this it is dangerous! ‘. I would be interested in why an MSC treatment is dubious in a certain clinic why the very same treatment in a clinical trial is promising? If it is because of the regulatory system or the environment, or the medical staff say that, but not the treatment. Or vica versa.

“Some of the best and brightest stem cell scientists in the country are barely surviving financially, not getting much in the way of grants, and are constantly under scrutiny for the validity of their results. If you want speed, if you want results, talk to CIRM, talk to the FDA, talk to the professors and researchers at the top universities researching the disease you want a cure for and ask them “Where do you get your funding?” or “What organization can I donate to that will help your research?””

You mean the patients? Ouch!!! In every enterprise, the owners or the investors have to come out with a business plan and the appropriate employees who can make it a success. You either come out with an idea that others will finance or you fail. And in the meantime, you have to produce results that investors buy. That is capitalism. Why should patients finance bogus researches? How they know if it is real science. You have to do, man. It is your salary. Come out with results and raise capital.

“My personal frustration with these sort of clinics is that, in all likelihood, they aren’t using stem cells at all, they just jack you full of some placebo that may or may not be cell based, and then pat themselves on the back, pointing to a handful of cases as proof that they are providing the miracle cure you’re looking for, taking in huge profits for an unproven placebo. ”

You are right. That is the real problem. How can you make the situation better? Baning and saying it to patients ‘don’t go abroad’ is a solution?

“So, rather than try to skew Paul’s words, if you want hope, go to the big company websites, go to CIRM’s website and see all the great work being done, go to clinicaltrials.gov and do some researching, but if you want straight-up, no non-sense stem cell information from a researcher with nothing to gain from you getting injected with stem cells, then Paul is your man”

If all the viewers can read and interpret the stem cell companies’ and CIRM’s websites, then why are they here? You are missing the point again. I am just wondering how well you can interpret clinical results as a ‘scientist’ when even doctors have problems doing so.
What do you mean by ” straight-up, no non-sense stem cell information” ? Isn’t this what others are looking for here? It is very interesting what is going on in a petri dish, but many people would be interested in stem cell research which is more advanced, like in clinical trial stages. And not just hamburgers made from stem cells :))
As a scientist “barely surviving financially”, you should know that you have to get closer to market to raise capital an get people’s interest. You have to have a product that you can sell one day. Investors will not finance you forever. 🙂

First of all things are not black and white. Not that easy to draw a line between legal and not-legal. Something is legal in one country and not in another. If a drug is approved in Japan it might not be in the USA. Gravity existed before Newton’s discovery. There are medicine practiced in for-profit clinics all around the world. We know the results of medical, phisiotherapy and rehabilitation practices in professional sports just by looking at the outsanding performance of athletes. Different surgeons might have different methods, none of them tested in clinical trials. And there are the off-label treatments.

Clinical trials. How can you test an autologous stem cell? Its efficacy will differ patient by patient.

An important thing, you forget that a person sentenced to death has nothing to lose. Many patients are aware that stem cells are not an approved cure, but they want to try it just as you do in a clinical trial. Most patients can not enter a clinical trial due to the very limited number of patients they accept. What is a scam? If a certain procedure is done in a clinical trial it is not a scam, but if the very same procedure is done out of a clinical trial, it is a scam. I see.

As Steve mentioned it nothing is said about promising clinical trials on your site. Let’s check Neuralstem and Brainstorm on ALS!

As for safety. Many times the problem is not that a heart surgery is performed, but whether it is performed properly. And as you know they are clinics where you wouldn’t like to get even a simple surgery.

Sanjay, I appreciate your comment. I do post both positive and negative pieces. However, in the stem cell clinic world things are more challenging in terms of writing about it because these are private, for-profit companies. They are very different, for example, than NeuralStem, which I agree is doing some positive work. In fact, in my book, I highlighted NeuralStem as one of the good citizens of the stem cell for-profit world.

A researcher has a different philosophical approach in any new treatment (drug) than a medical doctor (medical procedure). A researcher has FDA protocols that are mostly geared towards massively produced chemical drugs that can reach thousands of patients in a short period of time, so justifiably, the drug or in this case autologous stem cells have to be deemed potentially harmful first, and then proven safe. Their “guilty first until proven innocent” approach is not the same for medical procedures. Autologous stem cells have been shifted away from medical state board’s jurisdiction that considers patient’s risk to the level of riskiness in a unique procedure into a more cumbersome FDA guilty first protocol. A perfect example of this is which defies that logic is the first heart transplant performed. I think you cannot get more venturesome than having heart from another person to a different host. Besides, autologous stem cells are uniquely yours and not massively produced even after minimal manipulation threshold UNDER PROPER PROTOCOLS, so they are a lot safer than a heart transplant. And how did we get to this point, oh yea, when the FDA made a change to a regulation overnight without telling anybody which violates the APA. They literally changed one word in 1271 so that the regulation went from “into another human” to “into a human”. Abracadabra, FDA now regulates autologous stem cells, and researchers have embraced it with all their scientific mindset of testing and more testing while grants and royalties pour into the system and patients sit on the sidelines suffering and dying. You and I know this is not right!

Interesting conversation all the way around, but quite repetitive to say the least. I agree with Alberto, there is a fundamental difference with a bench scientist doing research, and the patient community. A meeting of the minds is nowhere in sight. As I’ve stated to Paul many times before, the real life experiences that patients are seeing don’t even come close to adding up to the warnings put forth by this blog. The FDA is “ultra vires” denying a no option patient the right to at least try treatment with their own cells. All doctors offering this treatment aren’t quacks. All clinics offering adult stem cell treatments aren’t shady establishments selling “snake oil.” Here’s the deal. We know which doctors to go to, we know which hospitals are top notch! We know where patients are seeing results. The patient community has been educating each other and sharing information about this for the past 10 years.
It’s unrealistic to think that if the medical establishment has nothing to offer a “no option patient” that we aren’t going to go figure it out for ourselves….and that’s exactly what we’ve done. No cures to report yet, but definitely steps in the right direction! Steps that no FDA approved drug has even come close to providing!http://wwwmsviewsandrelatednews.blogspot.com/2014/01/whats-skinny-on-when-and-why-fda.html